A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Allergic Bronchopulmonary Aspergillosis Clinical Trial

— RIA  

Official title:

A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440009
• Other study ID #: Histo-15-IMEC-313
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2014
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2022
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

Description:

The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory.

Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent ABPA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: July 31, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following:

• asthma

• immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels >0.35 kUA/L

• elevated total IgE levels >1000 IU/mL and, two of the following features:

• presence of precipitating antibodies against A.fumigatus in serum

• fixed or transient radiographic pulmonary opacities

• total eosinophil count >1000/µL

• bronchiectasis on HRCT chest

Exclusion Criteria:

• Intake of systemic glucocorticoids for more than three weeks in the preceding six months

• Exposure to azoles in the last six months

• Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others

• Patient on immunosuppressive drugs

• Pregnancy

• Enrollment in another trial of ABPA

• Failure to provide informed consent

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Itraconazole
Oral itraconazole 200 mg BD for 6 months
• Glucocorticoids
Oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months.

Locations

Country	Name	City	State
India	Chest Clinic, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse rates	Doubling of the baseline IgE levels irrespective of the patient's symptoms or appearance of radiologic infiltrates; or clinical and/or radiological worsening with 50% increase in IgE over the previous baseline value	12 months
Primary	Glucocorticoid-dependent ABPA	If the patient has relapse on two or more consecutive occasions within 6 months of stopping treatment or requires oral steroids for control of asthma	24 months
Secondary	Proportion of patients with a response rates		Six weeks
Secondary	Percentage decline in IgE		Six weeks
Secondary	Time to first relapse		Two years
Secondary	Treatment-related adverse effects		Six months